Safety and Pharmacokinetics/Pharmacodynamics of SHR3824 in Patients With Hepatic Impairment (Single-Center, Open-label, Parallel-Group, Single-Dose Study)
试验速览
- 阶段
- 1 期
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- The maximum plasma concentration (Cmax) of SHR3824
研究概览
简要总结
Comparison of the pharmacokinetics/Pharmacodynamics of the SHR3824 in Patients With Mild, Moderate and Severe Hepatic Impairment Compared with Healthy Volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years to 75 years (inclusive)
- •Body mass index should be between 18 and 33 kg/m2 (inclusive) (ie, a measure of one's weight in relation to height)
- •Liver damage due to viral hepatitis, alcoholic liver disease, autoimmune hepatitis, primary biliary cirrhosis of the liver (except for patients with drug-induced liver injury)
排除标准
- •allergic to SGLT2 inhibitor analogues or any other similar structure;
- •lactose intolerance history or lactose intolerance;
- •Suspected or diagnosed as liver cancer or with other malignant tumors;
- •Alcoholic liver, autoimmune liver disease, liver transplantation history
研究组 & 干预措施
healthy volunteers
Drug: SHR3824 20mg/day, oral tablet, single dose
干预措施: SHR3824 (Drug)
Mild Hepatic Impairment
Drug: SHR3824 20mg/day, oral tablet, single dose
干预措施: SHR3824 (Drug)
Moderate Hepatic Impairment
Drug: SHR3824 20mg/day, oral tablet, single dose
干预措施: SHR3824 (Drug)
Severe Hepatic Impairment
Drug: SHR3824 20mg/day, oral tablet, single dose
干预措施: SHR3824 (Drug)
结局指标
主要结局
The maximum plasma concentration (Cmax) of SHR3824
时间窗: 72 hours after dosing
Cmax (a measure of the body's exposure to SHR3824) will be compared between normal hepatic function patients and mild or moderate or severe hepatic dysfunction patients.
The area under the plasma concentration-time curve (AUC) of SHR3824
时间窗: 72 hours after dosing
AUC (a measure of the body's exposure to SHR3824) will be compared between normal hepatic function patients and mild or moderate or severe hepatic dysfunction patients
次要结局
- The number of volunteers with adverse events as a measure of safety and tolerability(72 hours after dosing)